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A prospective, multicenter clinical study designed to explore the efficacy of adaptive therapy based on MRD status in patients with stage II-III non-small cell lung cancer(NSCLC) after treatment. Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRD-negative follow-up | Sham Comparator |
| |
| MRD-positive follow-up | No Intervention | ||
| MRD-positive adaptive therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy combined with immunization | Drug | MRD positive patients receive chemotherapy ± immune for 4 cycles before adaptive therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS | 3 years | MRD-positive patients were treated 3 years after intervention |
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Inclusion Criteria:
2) Appropriate liver function: total bilirubin ≤ 1.5× upper limit of normal (ULN), aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤2.5×ULN 3) Appropriate renal function: serum creatinine ≤1.25×ULN, or creatinine clearance ≥60 mL/min
8. Sign informed consent
Exclusion Criteria:
1) Prior interstitial lung disease, drug-induced interstitial disease, radiation pneumonia or REN requiring hormone therapy Any clinical evidence of active interstitial lung disease 2) In the investigator's judgment, there is a severe or uncontrollable systemic disease (e.g. unstable or uncompensable) Evidence of respiratory, heart, liver or kidney disease) 3) Any unstable systemic disease (including active infection, grade III hypertension, unstable angina, Congestive heart failure, liver, kidney or metabolic disease) 4) Can not accept oral administration, need intravenous high energy nutrition, prior surgery affecting absorption or live Patients with dynamic peptic ulcer
7. Functional level of patients with various organ lesions:
8. No R0 resection [ananatomical lobectomy/total pulmonary resection + systemic lymph node dissection (including at least 3 groups of N1) And 3 groups of N2 lymph nodes), both gross and microscopic incisal margins were negative].
9. Situations considered unsuitable for inclusion by other researchers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoru Tian | Contact | 18618330855 | xiaoru9u@163.com | |
| Yi Zhang, MD,PhD | Contact | steven9130@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Zhang, MD,PhD | Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Beijing | Eijing | 100043 | China |
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| ID | Term |
|---|---|
| D007114 | Immunization |
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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